Anterior Cruciate Ligament ReconstructionNCT02795247
Comparison of 3 Techniques for Recreation of Anterior Cruciate Ligament Anatomic Footprint
A study testing Anterior Cruciate Ligament Reconstruction in people with Anterior Cruciate Ligament Reconstruction, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the tomographic results of patients who underwent single-bundle anterior cruciate ligament reconstruction at the investigator's institution using the transtibial, accessory medial portal technique and the modified transtibial technique to determine which technique best recreates… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Anterior Cruciate Ligament Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2016to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting for single bundle ACL reconstruction, with or without associated partial meniscectomy or meniscal repair.
- Skeletally mature patients
- Patients who are able and willing to receive post-operative CT imaging of the affected knee
Who cannot join
- Previous ACL reconstruction in the studied knee
- Previous ACL injury or reconstruction in the contralateral kneeConcomitant non-ACL ligament reconstruction or osteotomy
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoCarolina Sports Center
Charlotte, North Carolina, 28207
About this study
Official title: Three Dimensional Computed Tomography Comparison of the Transtibial, Modified Transtibial and Anteromedial Portal Technique for Recreation of the Anterior Cruciate Ligament Anatomic Footprint
The purpose of this study is to compare the tomographic results of patients who underwent single-bundle anterior cruciate ligament reconstruction at the investigator's institution using the transtibial, accessory medial portal technique and the modified transtibial technique to determine which technique best recreates the anterior cruciate ligament anatomic footprint.
- Being tested
- Anterior Cruciate Ligament Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cruciate Ligament ReconstructionProcedure or surgery
Also called ACL Reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Transtibial Technique | Active comparator | Reconstruction of the ACL using the hybrid transtibial technique Receives: Procedure: Anterior Cruciate Ligament Reconstruction |
| Accessory Anteromedial Portal Technique | Active comparator | Reconstruction of the ACL using the accessory anteromedial portal technique Receives: Procedure: Anterior Cruciate Ligament Reconstruction |
| Transtibial Technique | Active comparator | Reconstruction of the ACL using the transtibial technique. Receives: Procedure: Anterior Cruciate Ligament Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D reconstructed CT imaging
Used to measure tunnel position.
Measured: 6 weeks Post-Operatively
Secondary outcomes (9)
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Change in IKDC subjective knee evaluation since before surgery
Measured: 6 weeks post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Change in KOOS since before surgery
Measured: 6 weeks post-operative
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Change in IKDC subjective knee evaluation since before surgery
Measured: 6 months post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Change in KOOS since before surgery
Measured: 6 months post-operative
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Change in IKDC subjective knee evaluation since before surgery
Measured: 1 year post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Change in KOOS since before surgery
Measured: 1 year post-operative
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Change in IKDC subjective knee evaluation since before surgery
Measured: 2 year post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Change in KOOS since before surgery
Measured: 2 year post-operative
Knee Laxity
Pivot shift test will be used to a measure of knee laxity
Measured: 6 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start26 Aug 2016
- Primary completion27 Apr 2018
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana P Piasecki, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795247
- Sponsor's protocol ID
- SPORT037
- Status last verified
- Apr 2024
- First submitted
- 6 Jun 2016
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Robin BN, Jani SS, Marvil SC, Reid JB, Schillhammer CK, Lubowitz JH. Advantages and Disadvantages of Transtibial, Anteromedial Portal, and Outside-In Femoral Tunnel Drilling in Single-Bundle Anterior Cruciate Ligament Reconstruction: A Systematic Review. Arthroscopy. 2015 Jul;31(7):1412-7. doi: 10.1016/j.arthro.2015.01.018. Epub 2015 Mar 5.
PubMed 25749530Youm YS, Cho SD, Eo J, Lee KJ, Jung KH, Cha JR. 3D CT analysis of femoral and tibial tunnel positions after modified transtibial single bundle ACL reconstruction with varus and internal rotation of the tibia. Knee. 2013 Aug;20(4):272-6. doi: 10.1016/j.knee.2012.10.024. Epub 2012 Nov 26.
PubMed 23195998Lee MC, Seong SC, Lee S, Chang CB, Park YK, Jo H, Kim CH. Vertical femoral tunnel placement results in rotational knee laxity after anterior cruciate ligament reconstruction. Arthroscopy. 2007 Jul;23(7):771-8. doi: 10.1016/j.arthro.2007.04.016.
PubMed 17637414Alentorn-Geli E, Lajara F, Samitier G, Cugat R. The transtibial versus the anteromedial portal technique in the arthroscopic bone-patellar tendon-bone anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2010 Aug;18(8):1013-37. doi: 10.1007/s00167-009-0964-0. Epub 2009 Nov 10.
PubMed 19902178Takeda Y, Iwame T, Takasago T, Kondo K, Goto T, Fujii K, Naruse A. Comparison of tunnel orientation between transtibial and anteromedial portal techniques for anatomic double-bundle anterior cruciate ligament reconstruction using 3-dimensional computed tomography. Arthroscopy. 2013 Feb;29(2):195-204. doi: 10.1016/j.arthro.2012.08.020. Epub 2012 Dec 24.
PubMed 23270788de Abreu-e-Silva GM, de Oliveira MH, Maranhao GS, Deligne Lde M, Pfeilsticker RM, Novais EN, Nunes TA, de Andrade MA. Three-dimensional computed tomography evaluation of anterior cruciate ligament footprint for anatomic single-bundle reconstruction. Knee Surg Sports Traumatol Arthrosc. 2015 Mar;23(3):770-6. doi: 10.1007/s00167-013-2703-9. Epub 2013 Oct 22.
PubMed 24146049Larson AI, Bullock DP, Pevny T. Comparison of 4 femoral tunnel drilling techniques in anterior cruciate ligament reconstruction. Arthroscopy. 2012 Jul;28(7):972-9. doi: 10.1016/j.arthro.2011.12.015. Epub 2012 Mar 10.
PubMed 22409948Osaki K, Okazaki K, Matsubara H, Kuwashima U, Murakami K, Iwamoto Y. Asymmetry in Femoral Tunnel Socket Length During Anterior Cruciate Ligament Reconstruction With Transportal, Outside-In, and Modified Transtibial Techniques. Arthroscopy. 2015 Dec;31(12):2365-70. doi: 10.1016/j.arthro.2015.06.026. Epub 2015 Aug 24.
PubMed 26315055Bernard M, Hertel P, Hornung H, Cierpinski T. Femoral insertion of the ACL. Radiographic quadrant method. Am J Knee Surg. 1997 Winter;10(1):14-21; discussion 21-2.
PubMed 9051173Forsythe B, Kopf S, Wong AK, Martins CA, Anderst W, Tashman S, Fu FH. The location of femoral and tibial tunnels in anatomic double-bundle anterior cruciate ligament reconstruction analyzed by three-dimensional computed tomography models. J Bone Joint Surg Am. 2010 Jun;92(6):1418-26. doi: 10.2106/JBJS.I.00654.
PubMed 20516317Sohn OJ, Lee DC, Park KH, Ahn HS. Comparison of the Modified Transtibial Technique, Anteromedial Portal Technique and Outside-in Technique in ACL Reconstruction. Knee Surg Relat Res. 2014 Dec;26(4):241-8. doi: 10.5792/ksrr.2014.26.4.241. Epub 2014 Dec 2.
PubMed 25505707Trofa DP, Saltzman BM, Corpus KT, Connor PM, Fleischli JE, Piasecki DP. A Hybrid Transtibial Technique Combines the Advantages of Anteromedial Portal and Transtibial Approaches: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Nov;48(13):3200-3207. doi: 10.1177/0363546520956645. Epub 2020 Oct 5.
PubMed 33017169
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Computed Tomography Comparison of the Transtibial, Modified Transtibial and Anteromedial Portal Technique for Recreation of the Anterior Cruciate Ligament Anatomic Footprint
- ClinicalTrials.gov ID
- NCT02795247
- Acronym / sponsor ID
- SPORT037
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the tomographic results of patients who underwent single-bundle anterior cruciate ligament reconstruction at the investigator's institution using the transtibial, accessory medial portal technique and the modified transtibial technique to determine which technique best recreates the anterior cruciate ligament anatomic footprint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hybrid Transtibial Technique | Active comparator | Procedure: Anterior Cruciate Ligament ReconstructionReconstruction of the ACL using the hybrid transtibial technique |
| Accessory Anteromedial Portal Technique | Active comparator | Procedure: Anterior Cruciate Ligament ReconstructionReconstruction of the ACL using the accessory anteromedial portal technique |
| Transtibial Technique | Active comparator | Procedure: Anterior Cruciate Ligament ReconstructionReconstruction of the ACL using the transtibial technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting for single bundle ACL reconstruction, with or without associated partial meniscectomy or meniscal repair.
- Skeletally mature patients
- Patients who are able and willing to receive post-operative CT imaging of the affected knee
Key exclusion criteria (2 listed)
- Previous ACL reconstruction in the studied knee
- Previous ACL injury or reconstruction in the contralateral kneeConcomitant non-ACL ligament reconstruction or osteotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Cruciate Ligament ReconstructionAlso: ACL Reconstruction | Procedure or surgery | Accessory Anteromedial Portal Technique, Hybrid Transtibial Technique, Transtibial Technique |
Primary outcome
3D reconstructed CT imaging
Time frame: 6 weeks Post-Operatively
Used to measure tunnel position.
9 secondary outcomes
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Time frame: 6 weeks post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 weeks post-operative
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Time frame: 6 months post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 months post-operative
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Time frame: 1 year post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1 year post-operative
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Time frame: 2 year post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 2 year post-operative
Knee Laxity
Time frame: 6 month post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 25749530Robin BN, Jani SS, Marvil SC, Reid JB, Schillhammer CK, Lubowitz JH. Advantages and Disadvantages of Transtibial, Anteromedial Portal, and Outside-In Femoral Tunnel Drilling in Single-Bundle Anterior Cruciate Ligament Reconstruction: A Systematic Review. Arthroscopy. 2015 Jul;31(7):1412-7. doi: 10.1016/j.arthro.2015.01.018. Epub 2015 Mar 5.
- Background: PubMed 23195998Youm YS, Cho SD, Eo J, Lee KJ, Jung KH, Cha JR. 3D CT analysis of femoral and tibial tunnel positions after modified transtibial single bundle ACL reconstruction with varus and internal rotation of the tibia. Knee. 2013 Aug;20(4):272-6. doi: 10.1016/j.knee.2012.10.024. Epub 2012 Nov 26.
- Background: PubMed 17637414Lee MC, Seong SC, Lee S, Chang CB, Park YK, Jo H, Kim CH. Vertical femoral tunnel placement results in rotational knee laxity after anterior cruciate ligament reconstruction. Arthroscopy. 2007 Jul;23(7):771-8. doi: 10.1016/j.arthro.2007.04.016.
- Background: PubMed 19902178Alentorn-Geli E, Lajara F, Samitier G, Cugat R. The transtibial versus the anteromedial portal technique in the arthroscopic bone-patellar tendon-bone anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2010 Aug;18(8):1013-37. doi: 10.1007/s00167-009-0964-0. Epub 2009 Nov 10.
- Background: PubMed 23270788Takeda Y, Iwame T, Takasago T, Kondo K, Goto T, Fujii K, Naruse A. Comparison of tunnel orientation between transtibial and anteromedial portal techniques for anatomic double-bundle anterior cruciate ligament reconstruction using 3-dimensional computed tomography. Arthroscopy. 2013 Feb;29(2):195-204. doi: 10.1016/j.arthro.2012.08.020. Epub 2012 Dec 24.
- Background: PubMed 24146049de Abreu-e-Silva GM, de Oliveira MH, Maranhao GS, Deligne Lde M, Pfeilsticker RM, Novais EN, Nunes TA, de Andrade MA. Three-dimensional computed tomography evaluation of anterior cruciate ligament footprint for anatomic single-bundle reconstruction. Knee Surg Sports Traumatol Arthrosc. 2015 Mar;23(3):770-6. doi: 10.1007/s00167-013-2703-9. Epub 2013 Oct 22.
- Background: PubMed 22409948Larson AI, Bullock DP, Pevny T. Comparison of 4 femoral tunnel drilling techniques in anterior cruciate ligament reconstruction. Arthroscopy. 2012 Jul;28(7):972-9. doi: 10.1016/j.arthro.2011.12.015. Epub 2012 Mar 10.
- Background: PubMed 26315055Osaki K, Okazaki K, Matsubara H, Kuwashima U, Murakami K, Iwamoto Y. Asymmetry in Femoral Tunnel Socket Length During Anterior Cruciate Ligament Reconstruction With Transportal, Outside-In, and Modified Transtibial Techniques. Arthroscopy. 2015 Dec;31(12):2365-70. doi: 10.1016/j.arthro.2015.06.026. Epub 2015 Aug 24.
- Background: PubMed 9051173Bernard M, Hertel P, Hornung H, Cierpinski T. Femoral insertion of the ACL. Radiographic quadrant method. Am J Knee Surg. 1997 Winter;10(1):14-21; discussion 21-2.
- Background: PubMed 20516317Forsythe B, Kopf S, Wong AK, Martins CA, Anderst W, Tashman S, Fu FH. The location of femoral and tibial tunnels in anatomic double-bundle anterior cruciate ligament reconstruction analyzed by three-dimensional computed tomography models. J Bone Joint Surg Am. 2010 Jun;92(6):1418-26. doi: 10.2106/JBJS.I.00654.
- Background: PubMed 25505707Sohn OJ, Lee DC, Park KH, Ahn HS. Comparison of the Modified Transtibial Technique, Anteromedial Portal Technique and Outside-in Technique in ACL Reconstruction. Knee Surg Relat Res. 2014 Dec;26(4):241-8. doi: 10.5792/ksrr.2014.26.4.241. Epub 2014 Dec 2.
- Derived from this study: PubMed 33017169Trofa DP, Saltzman BM, Corpus KT, Connor PM, Fleischli JE, Piasecki DP. A Hybrid Transtibial Technique Combines the Advantages of Anteromedial Portal and Transtibial Approaches: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Nov;48(13):3200-3207. doi: 10.1177/0363546520956645. Epub 2020 Oct 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana P Piasecki, MD principal investigator
OrthoCarolina Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Cruciate Ligament Reconstruction in people with Anterior Cruciate Ligament Reconstruction, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D reconstructed CT imaging (time frame: 6 weeks Post-Operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795247, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.